Qiagen Sciences LLC Recall 87205
Description: SARS-CoV-2 Antigen Test
Qiagen Sciences LLC Recall 87205 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0941-2021 |
| Event ID | 87205 |
| Event Description | SARS-CoV-2 Antigen Test |
| Product Type | Devices |
| Distribution | Domestic: AZ, CA, DC, CO,FL,HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY |
| Quantity | 1092 boxes of 60 (65,520 e-sticks) |
| Recall Reason | QIAGEN has become aware of the potential for false positive results to occur with some patient samples. |
| Device Classification | 20210210 |
| Device Code Info | GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659. |
| Center Classification Date | 20210131 |
| Recall Initiation Date | 20210115 |
| Recalling Firm | Qiagen Sciences LLC |
| Initial Notification | Other |
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